BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment

NCT03860311 | Completed Results FDA Device

• 1 other identifier: IRB-300002071
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

In this study patients presenting to the pediatric ER with abdominal or pelvic complaints will be randomized to urethral bladder catheter or bladder ultrasound to compare time to completion of successful pelvic ultrasound, as determined by full visualization of uterus and ovaries.

Conditions

Point-of-Care Bladder Ultrasound; Urethral Catheter

Keywords

Ovarian Torsion; Point-of-Care; Pelvic pain; Bedside Ultrasound

Outcome Measures

Primary Outcomes (1)

• Time to Successful Completion of Pelvic Ultrasound

  Time zero (order placed) to time completed (time pelvic ultrasound images are completed)

  Baseline to 180 minutes

Secondary Outcomes (1)

• Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)

  When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes

Study Arms (2)

Bladder Ultrasound

EXPERIMENTAL

The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan.

Device: Bladder Ultrasound

Standard of Care

ACTIVE COMPARATOR

Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder.

Other: Standard of Care

Interventions

Bladder Ultrasound DEVICE

Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is "full," or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound.

Bladder Ultrasound

Standard of Care OTHER

Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures.

Standard of Care

Eligibility Criteria

• Age: 8 Years - 18 Years
• Gender Eligibility Details: Participants will be females visiting the emergency department for abdominal, vaginal, or possible genitourinary-related complaints, which may include abdominal pain, vaginal discharge, pelvic bleeding, flank pain, or vomiting, and for which treating physicians have a concern for pelvic pathology, such as ovarian torsion, ovarian cysts, or other ovarian or uterine pathology.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8yr-18yrs
• Female
• Likely to have order placed for transabdominal pelvic ultrasound/ovarian ultrasound
• No history of pelvic or bladder reconstructive surgery

You may not qualify if:

• Pregnancy (known)
• Critically ill patients
• Patients with known renal or genitourinary structural abnormalities or prior pelvic/genitourinary surgery
• Chronic renal disease
• Patients presenting outside the defined treatment windows

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Ovarian Torsion; Pelvic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Torsion Abnormality; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Stephen Ruffenach
• Organization: UAB

stephenruffenach@gmail.com

5202707665

Study Officials

• Kathleen R Richard, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 1, 2019
• Study Start: July 20, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 1, 2022
• Results First Posted: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)